## Facts

- Charles McCorvey underwent prostate surgery in February 1995 and was fitted postoperatively with a Bard 30-cc Foley catheter distributed by Baxter.
- The catheter’s written instructions limited balloon inflation to no more than 36 cc of sterile water.
- McCorvey’s physician tested the catheter by inflating the balloon to 50 cc of saline, deflated it, inserted it, and then reinflated it to 50 cc of saline.
- About six hours later, the catheter balloon ruptured and fragmented inside McCorvey.
- Hospital staff removed and discarded the catheter; McCorvey later reported persistent urinary symptoms.
- Approximately 18 months later, a physician found an additional balloon fragment lodged in McCorvey’s prostate.
- McCorvey sued the manufacturer and distributor under Florida strict products-liability theory, alleging a defect caused the rupture and injuries.

## Issues

1. Whether the district court abused its discretion under Fed. R. Evid. 702 and *Daubert* by excluding McCorvey’s engineering expert affidavit as unreliable.
2. Whether Florida’s Cassisi malfunction inference applied when the catheter was inflated beyond the stated maximum and with saline rather than sterile water.
3. Whether summary judgment was proper given the exclusion of expert evidence and the unavailability of the Cassisi inference.

## Decision

- The court affirmed the exclusion of the expert affidavit, finding no abuse of discretion under Rule 702 and *Daubert*.
- The court held McCorvey was not entitled to the Cassisi malfunction inference because the catheter was not used in normal or intended operation under the manufacturer’s instructions.
- The court affirmed summary judgment for the manufacturer and distributor because McCorvey lacked admissible evidence creating a triable issue on defect and causation.

## Legal Principles

- Under Fed. R. Evid. 702 and *Daubert*, the proponent of expert testimony bears the burden to show admissibility by a preponderance of the evidence, including a reliable basis and an explained methodology linking conclusions to data.
- A conclusory expert opinion that does not describe testing, methodology, or analysis of alternative causes may be excluded as unreliable.
- Under Florida law, the Cassisi inference permits an inference of defect when a product malfunctions during normal operation, supporting defect at sale and at injury absent proof of a specific defect.
- The Cassisi inference does not arise when the product’s use materially departs from clear manufacturer instructions; customary professional practice does not convert an expressly prohibited use into “normal operation” for purposes of the inference.

## Conclusion

The Eleventh Circuit affirmed judgment for the manufacturer and distributor because the plaintiff’s defect expert was properly excluded as unreliable and the catheter’s malfunction did not trigger Florida’s Cassisi inference where physicians inflated the balloon contrary to explicit instructions, leaving no admissible evidence of defect or causation.


McCorvey v. Baxter Healthcare Corp., 298 F.3d 1253 (11th Cir. 2002)